Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Recurrent Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT00003777|
Recruitment Status : Unknown
Verified November 2002 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : December 10, 2003
Last Update Posted : February 9, 2009
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as amifostine may prevent the side effects of radiation therapy. Combining more than one drug and combining radiation therapy and surgery with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining surgery, radiation therapy, and combination chemotherapy in treating patients who have recurrent head and neck cancer that has been treated previously with radiation therapy.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: amifostine trihydrate Drug: cisplatin Drug: fluorouracil Procedure: surgical procedure Radiation: radiation therapy||Phase 2|
- Determine the effectiveness and toxic effects of intensive salvage therapy and radiotherapy in previously irradiated patients with recurrent head and neck cancer.
- Determine the feasibility and effectiveness of amifostine at limiting or minimizing side effects of repeat irradiation in these patients.
OUTLINE: Patients undergo surgical resection of gross disease (if not already done) followed by 4-6 weeks of rest. Patients receive radiotherapy over 5 consecutive days on weeks 1, 2, 4, and 5. Intravenous cisplatin is administered on days 1-3 and 29-31. Intravenous amifostine is administered 15-30 minutes prior to radiotherapy and cisplatin therapy. Patients receive fluorouracil IV continuously on days 1-4 and 29-32.
Patients are followed every month for 1 year, every 2 months for 1 year, every 3 months for 1 year, every 4 months for 1 year, then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Official Title:||A Pilot Study of Combined Modality Therapy for Recurrent Head and Neck Carcinoma|
|Study Start Date :||December 1998|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003777
|United States, Pennsylvania|
|University of Pennsylvania Cancer Center|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|Study Chair:||Mitchell Machtay, MD||Abramson Cancer Center of the University of Pennsylvania|